Legend Biotech’s Carvykti (ciltacabtagene autoleucel) Receives the US FDA’s Approval for the Treatment of Multiple Myeloma
Shots:
- The US FDA has approved Carvykti for the treatment of adults with r/r MM who have received four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 mAb
- The approval was based on the P-II/III (CARTITUDE-1) study evaluating cilta-cel in 126 patients with r/r MM which showed deep and durable responses, ORR (98%) including 78% of patients achieved sCR, m-DOR (21.8mos.) at a median of 18mos. follow-up
- Carvykti is a BCMA-directed, genetically modified autologous T-cell immunotherapy & received BTD from the US FDA & NMPA, ODD from the US FDA & EMA. The therapy is available only through a restricted program under REMS
Ref: Businesswire | Image: Businesswire
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